Adverse Events l DSMB

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Adverse Events/ DSMB

Data Safety Monitoring Board: DSMB 6/18/08 Minutes
Next Meeting: December 2008

Adverse Events: 60A02 l 71103 l 97102 l 97202 l 97405 l 97106 l 91105
Included in the list below are all adverse events (AEs) and serious adverse events (SAEs) from the Wake Forest site and all participating site members. This page is updated the first Thursday of each month with new events received during the previous month. Sites should submit AEs/SAEs from other sites as well as those that occur locally, according to the policies and procedures of their IRB. For questions regarding this website, or to request a copy of a particular MedWatch AE/SAE form, please contact Sarah C. Hahne at (336) 716-5992 or at shahne@wfubmc.edu.
60A02 – Juice Plus

Event number
Date of Event
Main event (brief description)
Related to study drug?
1
10/25/04
Hospitalization for grade 4 pain due to neuropathy and grade 3 dehydration
No
2
06/16/05
ER presentation with grade 2 versus possible grade 4 mood alteration
No
3
07/26/05
Hospitalization for grade 3 pain and headache
No
4
10/17/05
Hospitalization for chills, cough, fever
No
5
12/07/05
Death at home during sleep.
No
6
12/11/05
Hospitalization for grade 3 ataxia; patient fell and had head injury
No
7
01/12/06
Hospitalized for grade 2 anorexia and grade 3 fatigue
No
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71103 – Depsipeptide, metastatic soft-tissue sarcoma

Event number
Date of Event
Main event (brief description)
Related to study drug?
1
01/28/05
Hospitalization for prolongation of QTC
Yes
2
04/16/05
Hospitalization for dehydration and infection
No
3
04/26/05
Hospitalization for prolongation of QTC
Yes
4
04/27/05
Hospitalization for grade 2 pain, fever, and grade 3 dehydration
No
5
05/03/05
Death from disease progression.
No
6
08/15/05
Hospitalization for grade 3 nausea, vomiting, dehydration, and grade 2 fever
No
7
08/23/05
Hospitalization for grade 4 dyspnea, hypoxia and pleural effusion
No
8
08/29/05
Hospitalization for grade 3 back and right thigh pain
No
9
9/15/05
Hospitalization for pain, hypoxia, dyspnea
No
10
10/11/05
Hospitalization for lower back pain
No
11
02/10/06
Asymptomatic prolongation of QT/QTC as demonstrated on EKG; grade 3
Yes
12
03/08/06
Hospitalization for grade 4 constipation, grade 3 nausea/vomiting, anemia, and grade 2 shortness of breath
No
13
03/25/06
Hospitalization for grade 3 dehydration, nausea and vomiting
No
14
03/28/06
Hospitalization for weakness
No
15
04/04/06
Death due to disease progression
No
July 2006
16
06/23/06
Hospitalization due to grade 3 dehydration
No
17
07/06/06
Hospitalization due to grade 3 dehydration, anorexia, fatigue, edema and grade 4 potassium
No
18
07/11/06
Death due to disease progression
No
August 2006
19
07/21/06
Asymptomatic prolongations of QT/QTc as demonstrated on EKG, grade 3
Yes
20
07/28/06
Grade 3 cardiac arrhythmia
Yes
October 2006
21
09/8/06
Hospitalization due to grade 2 dyspnea and pnemothorax and grade 3 back pain
No
22
09/20/06
Hospitalization due to grad 2 dyspnea
No
23
09/19/06
Hospitalization due to grade 3 hip pain and vision
No
24
09/24/06
Hospitalized for grade 3 chest pain and dyspnea
No
25
09/23/06
Hospitalization due to grade 3 abdominal pain, vomiting and nausea
No
November 2006
26
09/23/06
Hospitalization due to grade 3 abdominal pain, vomiting and nausea
No
27
10/20/06
Hospitalization due to grade 4 abdominal pain, grade 3 vomiting and dehydration
No
January 2007
28
11/03/06
Hospitalization due to grade 3 abdominal pain, diarrhea, grade 2 N & V
No
29
12/01/06
Hospitalization due to grade 2 edema and UTI
No
30
12/10/06
Death due to disease progression
No
February 2007
31
02/06/07
Hospitalization due to grade 4 secondary malignancy
No
May 2007
32
04/20/07
Hospitalization due to grade 3 pain
No
August 2007
33
08/08/07
Hospitalization due to grade 3 cardiac arrhythmia
Yes
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97102 – Oxandrin/Megace

Event Number
Date of Event
Main event (brief description)
Related to study drug?
1
06/25/04
Elevated liver functions
Yes
2
07/22/04
Hospitalization for grade 3 abdominal pain
No
3
08/11/04
Hospitalization for grade 3 shortness of breath
No
4
08/16/04
Grade 4 leucopenia
No
5
08/19/04
Hospitalization for grade 4 shortness of breath
No
6
08/25/04
Hospitalization for aspiration following accidental removal of feeding tube
No
7
10/20/04
Hospitalization for grade 3 neutropenic fever
No
8
11/16/04
Hospitalization for insertion of feeding tube, anorexia, and teeth extractions
No
9
11/20/04
Hospitalization for intractable nausea, vomiting, failure to thrive, dehydration
No
10
12/10/04
Hospitalization for two bleeding ulcers
No
11
12/23/04
Hospitalization for bilateral pulmonary emboli
No
12
12/09/04
Hospitalization for grade 3 dehydration
No
13
01/07/05
Hospitalization for culture neg sepsis syndrome
No
14
02/01/05
Hospitalization for peptic ulcer
No
15
02/19/05
Death due to fatal arrhythmia
No
16
03/16/05
Death due to disease progression
No
17
03/20/05
Hospitalization for surgical revision of transverse loop colostomy
No
18
03/23/05
Hospitalization for grade 3 dehydration
No
19
03/31/05
Hospitalization for small bowel obstruction
No
20
04/13/05
Death due to disease progression